Recruiting

Chatbot Tool

Sponsor:

University of Utah

Code:

NCT07410689

Conditions

Cancer

Financial Toxicity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rule-Based Chatbot

Hybrid Chatbot

Study Details

Brief summary:

This is a randomized, two-arm, parallel-group pilot trial investigating a new chatbot tool designed to support cancer patients and caregivers, particularly those in rural communities. Approximately 60 participants will be randomized 1:1 to interact with either a hybrid chatbot or an AI-enabled chatbot. Participants will use their assigned chatbot to obtain clear and helpful information related to insurance, travel costs, and other financial aspects of cancer care.

Conditions

Cancer

Financial Toxicity

Study ID

NCT07410689

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (18 years and older)
  • Cancer patients or financially responsible caregivers of cancer patients who:
  • Reside in the Huntsman Cancer Institute's five-state catchment area (Utah, Idaho, Wyoming, Montana, and Nevada),
  • Are able to read and write in English, and
  • Live in a rural area, defined by endorsement of a residential ZIP code classified as non-metropolitan (RUCA codes 4-10) per the USDA Rural-Urban Commuting Area Codes.

Exclusion Criteria:

  • Respondents who do not live within this 5-state region--The SAFE toolkit material was developed for the Huntsman Cancer Institute patient population which serves UT, ID, MT, WY, \& NV
  • Respondents who only speak Spanish or other exclusively non-English speaking groups--The large language model for the chatbot will be developed in the English language. As non-English language training for the chatbot is not part of the scope of this study, participants who are unable to read and write in English may not be appropriate. As such, we will not be recruiting participants who only speak Spanish or other exclusively non-English speaking groups. Future studies will include adaptation of the chatbot to other languages.
  • Caregivers who are not primarily responsible for the financial aspects of patients' cancer care--The topic of financial hardship of cancer care may be less relevant for caregivers who are not financially involved in care.
  • Non-rural dwelling

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Rule-based Chatbot

Participants randomized to this arm will be asked to use the rule-based chatbot.

other: Hybrid Chatbot

Participants randomized to this arm will be asked to use the hybrid chatbot

Interventions

Rule-Based Chatbot

The rule-based (scripted) SAFE.ai chatbot is a guided conversational tool built to provide structured, accurate, and consistent information to rural cancer patients and caregivers experiencing cancer-related financial toxicity.

This chatbot is grounded in the Self-Advocacy for Financial Empowerment (SAFE) resource toolkit, which was co-developed with a community advisory board (CAB) composed of rural patients, caregivers, nurses, and financial navigation experts across HCI's five-state catchment area. All scripted responses reflect priorities identified during qualitative needs assessment sessions, ensuring that content is culturally aligned with rural patient experiences and real-world financial challenges.

The chatbot follows a rule-based decision tree. Users progress through the conversation by selecting a response from a set of fixed options displayed on-screen. This ensures that all content is clinically vetted, safe, consistent, and aligned with evidence-based practices.

Hybrid Chatbot

The hybrid SAFE.ai chatbot builds on the existing rule-based system by integrating a large language model (LLM) layer to support more flexible, open-ended, and conversational interactions. While the rule-based chatbot provides structured conversations through predefined content, the hybrid approach allows users to ask complex or personalized questions about financial toxicity.

To ensure safety and accuracy, the hybrid chatbot is not allowed to generate responses from the open internet.

By combining the consistency of rule-based logic with the adaptability of an LLM, the hybrid chatbot will enable users to ask follow-up questions, describe nuanced financial situations, request clarification in their own words, and receive more tailored guidance while still ensuring adherence to SAFE content.

Primary outcome measure

  • Single-Item Helpfulness Rating [ Time Frame: up to 2 weeks ]
  • System Usability Scale (SUS) [ Time Frame: up to 2 weeks ]
  • Acceptability of Intervention Measure (AIM) [ Time Frame: up to 2 weeks ]
  • Chatbot User Satisfaction (CUS) - Satisfaction Subscale [ Time Frame: up to 2 weeks ]
  • Trust in Automated Systems Test (TOAST) [ Time Frame: up to 2 weeks ]

Central Contacts and Locations

Locations

Huntsman Cancer Institute/ University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Djin Tay, PhD, RN

801-646-6440Djin.Tay@nurs.utah.edu

Principal Investigator:

Djin Tay, PhD, RN

More Information

Sponsor

University of Utah

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Utah on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.